Qiagen has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its QIAstat-Dx respiratory SARS-CoV-2 panel test kit.
The QIAstat-Dx test kit is claimed to be the first and only syndromic solution designed to diagnose patients infected with the novel COVID-19 coronavirus.
Qiagen’s new test holds the capacity to differentiate the SARS-CoV-2 coronavirus from 20 other serious respiratory infections
Qiagen’s new test is said to differentiate the SARS-CoV-2 coronavirus from 20 other serious respiratory infections in patients who may exhibit similar symptoms in a single testing run of around one hour.
The multiplexed nucleic acid test can assess samples such as nasopharyngeal swabs collected from individuals suspected of respiratory tract infections.
The newly approved panel is comprised of assays that target two genes for the detection of the pathogen behind the severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) disease.
Qiagen’s new test has to be provided to CLIA-certified laboratories to conduct moderate and high complexity tests.
The EUA approval status follows the Qiagen’s announcement of supplying QIAstat-Dx SARS-CoV-2 test kits to the US, under a new FDA Policy.
The company shipped over 1,100 QIAstat-Dx instruments to the hospitals, clinics and laboratories across the world. More than 200 kits have been shipped to the US.
Recently, Qiagen announced that it will receive $598,000 in funding from the US Department of Health and Human Services to develop a QIAstat-Dx respiratory SARS-CoV-2 panel test kit.
Qiagen CEO Thierry Bernard said: “We are pleased to begin making QIAstat-Dx SARS-CoV-2 test kits available in the United States under the FDA’s emergency use authorization for clinical laboratories. The QIAstat-Dx syndromic panel adds an important tool for clinicians.
“I am proud of our QIAGEN teams working tirelessly to implement 24/7 production of test cartridges and testing components. In addition to QIAstat-Dx, we are supplying RNA extraction kits under the QIAamp and EZ1 brands as well as numerous components and instruments for use in fighting this public health crisis around the world.”
In March, Thermo Fisher Scientific agreed to acquire Qiagen in a deal valued at around $11.5bn. Based in the Netherlands, Qiagen provides life science and molecular diagnostic solutions to more than 500,000 customers across the globe.
